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藥物食品檢驗局調查研究年報
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| 篇名 | 市售茶鹼控釋性製劑之溶離度試驗調查 |
|---|---|
| 卷期 | 16 |
| 並列篇名 | Survey on the Dissolution Rate of Control-Released Preparations of Theophylline |
| 作者 | 蔡芳英 、 魏念慈 、 史濟振 、 陳金榮 |
| 頁次 | 029-036 |
| 關鍵字 | 茶鹼 、 控釋性製劑 、 溶離度試驗 、 Theophylline 、 Control-release 、 Preparations 、 Dissolution 、 TSCI |
| 出刊日期 | 199809 |
中文摘要
為瞭解市售茶鹼控釋性製劑之溶離度，及因應管理之需，本局自八十 五年七月一日至八十六年六月三十日止；於臺北市藥局（房）進行抽購茶鹼 控釋性製劑6件。依據美國藥典第二十三版所載茶鹼控釋性膠囊之溶離度測定 法進行試驗。結果顯示6件控釋性製劑之溶離度均不符合美國藥典第二十三版 對該製劑之要求。
英文摘要
This survey was conducted to understand the quality of dissolution rate of control-released preparations of Theophylline. 6 samples were purchased in local markets from the Taipei City area during the fiscal year of 1996. All the samples were investigated with reference to the requirements and the method for Theophylline extended-release capsules in the twenty-third edition of United States Pharmacopoeia. The result showed that all the samples failed to meet the requirements.